Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

Sponsor

Bitlis Eren University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05624060

Collaborator

Gazi University (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Fecal Incontinence Sexual Dysfunction Sexuality	Behavioral: Pelvic Floor Dysfunction Prevention Training Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise	N/A

Detailed Description

The research was conducted as a randomized controlled trial. The simple randomization method will be used for the assignment to groups. The data of the research; will be collected using the Preliminary Evaluation Form, Personal Information Form, Female Sexual Function Index, The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version), and Fecal Incontinence Severity Index. The research will start at the 34th week of pregnancy and the questionnaires will be administered in the 3rd month after delivery. There will be 3 groups in the research.An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Perineal Massage and Pelvic Floor Exercise Applied in the Antenatal Period on Postpartum Sexuality and Incontinence: A Randomized Controlled Study

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Pelvic Floor Dysfunction Prevention Training	Behavioral: Pelvic Floor Dysfunction Prevention Training The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.
Experimental: Experimental Group 1 Pelvic Floor Dysfunction Prevention Training and Perineal Massage	Behavioral: Pelvic Floor Dysfunction Prevention Training The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure. Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.
Experimental: Experimental Group 2 Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise	Behavioral: Pelvic Floor Dysfunction Prevention Training The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure. Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant. Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise Women assigned to this group will apply pelvic floor exercise at least 3 days a week 8-12 times a week, starting from the 34th week of pregnancy until delivery. In addition, women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Arm

Intervention/Treatment

Active Comparator: Control Group

Pelvic Floor Dysfunction Prevention Training

Behavioral: Pelvic Floor Dysfunction Prevention Training

The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.

Experimental: Experimental Group 1

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Behavioral: Pelvic Floor Dysfunction Prevention Training

Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Experimental: Experimental Group 2

Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

Behavioral: Pelvic Floor Dysfunction Prevention Training

Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

Women assigned to this group will apply pelvic floor exercise at least 3 days a week 8-12 times a week, starting from the 34th week of pregnancy until delivery. In addition, women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Outcome Measures

Primary Outcome Measures

Female Sexual Function Index [Postpartum 12th weeks]
In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain.The highest raw score that can be obtained from the scale is 95 and the lowest raw score is 4.After sub-dimension averages were multiplied by factor loads, the highest score that could be obtained from the scale was calculated as 36 and the lowest score as 2. High score means better function.
The International Consultation on Incontinence Questionnaire-ICIQ [Postpartum 12th weeks]
The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version) is a scale for evaluating every aspect of urinary incontinence and its impact on quality of life.It consists of 6 questions.The ICIQ Total Score is calculated by the sum of the 3+4+5 questions and scores between 0 and 21. If the score is high and close to 21, it shows that it is overly affected.
Fecal Incontinence Severity Index-FISI [Postpartum 12th weeks]
It is an index developed to diagnose the frequency and type of fecal incontinence.It defines the type of fecal incontinence in four types and its frequency in five categories. The index score is calculated by summing the numbers corresponding to each box and the patient score. In patient-weighted scoring, the highest score that can be obtained from the index is 61 and the lowest score is 0.The cut-off score of the index is 31.7.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

being over 18 years old,
being 32-34th pregnancy weeks,
being not experiencing any complications in the mother and fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.),
having a singleton pregnancy,
being primiparous
being volunteer to participate in the study

Exclusion Criteria:

elective cesarean section planning,
having a history of chronic constipation,
having a previous history of urinary or anal incontinence,
having genital infection with lesions (HSV, HPV, Syphilis, Candida Albicans, Chancroid)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bitlis Eren University
Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sultan OZKAN SAT, Assistant Professor, Bitlis Eren University

ClinicalTrials.gov Identifier:

NCT05624060

Other Study ID Numbers:

SULTANOZKANSAT

First Posted:

Nov 21, 2022

Last Update Posted:

Nov 21, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fecal Incontinence

Urinary Incontinence

Study Results

No Results Posted as of Nov 21, 2022